FDA Approves Surfaxin

WARRINGTON, Pa., March 6, 2012 /PRNewswire/ -- Discovery
Laboratories, Inc., a specialty biotechnology
company dedicated to advancing a new standard in respiratory
critical care, today announced that the United States Food and Drug
Administration (FDA) has approved Surfaxin (lucinactant) for the
prevention of Respiratory Distress Syndrome (RDS) in premature
infants at high risk for RDS. Surfaxin is the first
synthetic, peptide-containing surfactant approved for use in
neonatal medicine. Discovery Labs anticipates that Surfaxin
will be commercially available in the United States in late
2012.

"The approval of Surfaxin is an important medical advancement
for the neonatology community and parents of preterm infants who
will soon have an effective alternative to animal-derived
surfactants to prevent the development of RDS," said W. Thomas
Amick, Chairman of the Board and Chief Executive Officer of
Discovery Labs. "This is a significant milestone in our
continuing efforts to develop a pipeline of products to further
advance the standard of respiratory critical care."

RDS is a condition in which premature infants are born with an
insufficient amount of pulmonary surfactant, a substance produced
naturally in the lungs and essential for breathing. Today,
infants with RDS often require animal-derived surfactant
replacement therapy along with mechanical ventilation to
survive. Approximately 90,000 premature infants in the United
States are treated annually with currently available animal-derived
surfactants.

About Surfaxin

Surfaxin (lucinactant intratracheal suspension) is a synthetic,
peptide-containing surfactant. Surfaxin is indicated for the
prevention of respiratory distress syndrome (RDS) in premature
infants at high risk for RDS. The safety and efficacy of
Surfaxin for the prevention of RDS in premature infants was
demonstrated in a large, multinational phase 3 clinical program
that included 1294 patients. Discovery Labs anticipates that
Surfaxin will be commercially available in late 2012.

Important Safety Information

Surfaxin (lucinactant intratracheal suspension) is intended for
intratracheal use only. The administration of exogenous
surfactants, including Surfaxin, can rapidly affect oxygenation and
lung compliance. Surfaxin should be administered only by
clinicians trained and experienced with intubation, ventilator
management, and general care of premature infants in a highly
supervised clinical setting. Infants receiving Surfaxin should
receive frequent clinical assessments so that oxygen and
ventilatory support can be modified to respond to changes in
respiratory status.

Most common adverse reactions associated with the use of
Surfaxin are endotracheal tube reflux, pallor, endotracheal tube
obstruction, and need for dose interruption. During Surfaxin
administration, if bradycardia, oxygen desaturation, endotracheal
tube reflux, or airway obstruction occurs, administration should be
interrupted and the infant's clinical condition assessed and
stabilized. Surfaxin is not indicated for use in acute
respiratory distress syndrome (ARDS).

About Discovery Labs

Discovery Laboratories, Inc. is a specialty biotechnology
company with one focus – to advance a new standard in
respiratory critical care. Discovery Labs' novel proprietary
KL4 surfactant technology produces a synthetic, peptide-containing
surfactant that is structurally similar to pulmonary surfactant and
is being developed in liquid, lyophilized, and aerosolized dosage
forms. Discovery Labs is also developing its proprietary drug
delivery technologies to enable efficient delivery of aerosolized
KL4 surfactant and other inhaled therapies. Discovery Labs believes
that its proprietary technologies make it possible, for the first
time, to develop a significant pipeline of products to address a
variety of respiratory diseases for which there frequently are few
or no approved therapies. For more information, please visit
our website at www.Discoverylabs.com.

Forward-Looking Statements

To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from the statements
made. Examples of such risks and uncertainties, including those
related to the timing of a commercial launch of Surfaxin and market
acceptance of Surfaxin, are described in Discovery Labs' filings
with the Securities and Exchange Commission including the most
recent reports on Forms 10-K, 10-Q and 8-K, and any amendments
thereto. Any forward-looking statement in this release speaks only
as of the date on which it is made. The Company assumes no
obligation to update or revise any forward-looking statements.

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